Cognitive Behavioral Strategies and Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder: Open Label Study (CBT-TMS)

The purpose of this study is to evaluate the effectiveness of repetitive TMS (rTMS) delivered simultaneously with elements of cognitive behavioral therapy/exposure-response prevention (CBT/ERP) in adult subjects (greater or equal to 18 years old) with obsessive-compulsive disorder (OCD). This is an open label study that involves standard of care for OCD (CBT) and an investigational treatment modality (TMS). The investigators will compare the Yale-Brown Obsessive Compulsive Scale (YBOCS) scores before and after treatment to quantify clinical improvement. The side effects from TMS include, but are not limited to, headache, seizure, and general pain. CBT has minimal side effects other than mental discomfort during the exposure sessions. For safety concerns, pregnant women and subjects with seizure-related history will be excluded as well as other indicated conditions in the details protocol.

Study Overview

• Status: Terminated
• Conditions: Obsessive Compulsive Disorder (OCD)
• Intervention / Treatment: Behavioral: Cognitive behavioral therapy; Device: Transcranial magnetic stimulation

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to qualify for enrollment into the study:

1. All subjects will be 18 - 65 years of age.

2. Obsessive-compulsive disorder:

   • Subjects will meet the DSM-IV primary diagnosis of obsessive-compulsive
   • Y-BOCS total score > 16
3. Subjects are willing and able to adhere to the intensive treatment schedule and all required study visits.

Exclusion Criteria

Subjects will be excluded from study participation if one of the following exclusion criteria applies:

1. Subjects are unable or unwilling to give informed consent.
2. No exclusion criteria for comorbid DSM diagnosis.

3. Subjects with a clinically defined neurological disorder that caused significant safety concern to receive TMS treatment, including, but not limited to:

   • Any condition likely to be associated with increased intracranial pressure.
   • Space occupying brain lesion.
   • Any history of seizure EXCEPT those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study).
   • History of stroke.
   • Transient ischemic attack within two years.
   • Cerebral aneurysm.
   • Dementia.
   • Mini Mental Status Exam (MMSE-2) score of <24.
   • Parkinson's disease.
   • Huntington's disease.
   • Multiple sclerosis.
   • Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold. Medications that lower the seizure threshold are included in the Prohibited Concomitant Medication (Section 5.8).

4. Subjects with any of the following treatment histories:

   • TMS treatment within 6 months prior to the screening visit.
   • Lifetime history of treatment with Deep Brain Stimulation
   • Use of any investigational drug or device within 4 weeks of the randomization visit.
   • If participating in psychotherapy, must have been in stable treatment for at least 2 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the trial.
   • Recent 2-month medication changes

5. Contraindication to receive TMS:

   • Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
   • Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, stents, or electrodes) or any other metal object within or near the head, excluding the mouth, which cannot be safely removed.
   • Clinically significant abnormality or clinically significant unstable medical condition, as indicated by medical history, physical examination, ECG results, or clinical laboratory testing, that in the Investigator's judgment might pose a potential safety risk to the subject or limit interpretation of the trial results, e.g., any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary and renal malfunctioning.
6. Women who are currently pregnant or not using a medically acceptable means of birth control and women who are breastfeeding.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rTMS and Cognitive Behavior Therapy	Behavioral: Cognitive behavioral therapy; Device: Transcranial magnetic stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remission Rate, as Measured by Y-BOCS	Remission is defined as end-point Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score less than the value of 16.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response, as Measured by Y-BOCS	Complete response is defined as a reduction of Y-BOCS score greater than 35%.	6 weeks
Partial Response Rate, as Measured by Y-BOCS	Partial response is defined as a reduction of greater than 25%.	6 weeks
Percentage of Adverse Events		6 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Richard Weiner, MD, Duke University

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: August 17, 2015
• First Submitted That Met QC Criteria: August 17, 2015
• First Posted (Estimate): August 19, 2015

Study Record Updates

• Last Update Posted (Estimate): February 9, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Transcranial magnetic stimulation (TMS); Cognitive behavioral therapy (CBT)
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: Pro00047168